Cognitive effects of pregabalin in healthy volunteers: A double-blind, placebo-controlled trial -- Salinsky et al. 74 (9): 755 -- Neurology

Cognitive effects of pregabalin in healthy volunteers: A double-blind, placebo-controlled trial — Salinsky et al. 74 (9): 755 — Neurology.

This Article Figures Only Full Text Full Text (PDF) Data Supplement Correspondence:

Submit a response Alert me when this article is cited Alert me when Correspondence are posted Alert me if a correction is posted Services Email this article to a friend Similar articles in this journal Alert me to new issues of the journal Download to citation manager Request Permissions Google Scholar Articles by Salinsky, M. Articles by Munoz, S. PubMed Articles by Salinsky, M. Articles by Munoz, S. Related Collections Class I Antiepileptic drugs

NEUROLOGY 2010;74:755-761

© 2010 American Academy of Neurology

Cognitive effects of pregabalin in healthy volunteers

A double-blind, placebo-controlled trial Martin Salinsky, MD, Daniel Storzbach, PhD andSonia Munoz, MD

From the Oregon Health & Science University, Portland.

Address correspondence and reprint requests to Dr. Martin Salinsky, 3181 SW Sam Jackson Park Road, CR-120, Portland, OR 97239 Salinsky@ohsu.edu.

Background: Antiepileptic drugs (AEDs) can be associated withneurotoxic side effects including cognitive dysfunction, a problemof considerable importance given the usual long-term courseof treatment. Pregabalin is a relatively new AED widely usedfor the treatment of seizures and some types of chronic painincluding fibromyalgia. We measured the cognitive effects of12 weeks of pregabalin in healthy volunteers.

Methods: Thirty-two healthy volunteers were randomized in adouble-blind parallel study to receive pregabalin or placebo(1:1). Pregabalin was titrated over 8 weeks to 600 mg/d. Atbaseline, and after 12 weeks of treatment, all subjects underwentcognitive testing. Test-retest changes in all cognitive andsubjective measures were Zscored against test-retest regressionspreviously developed from 90 healthy volunteers. Z scores fromthe placebo and pregabalin groups were compared using Wilcoxontests.

Results: Thirty subjects completed the study (94%). Three of6 target cognitive measures (Digit Symbol, Stroop, ControlledOral Word Association) revealed significant test-retest differencesbetween the pregabalin and placebo groups, all showing negativeeffects with pregabalin (p < 0.05). These cognitive effectswere paralleled by complaints on the Portland NeurotoxicityScale, a subjective measure of neurotoxicity (p < 0.01).

Conclusion: At conventional doses and titration, pregabalininduced mild negative cognitive effects and neurotoxicity complaintsin healthy volunteers. These effects are one factor to be consideredin the selection and monitoring of chronic AED therapy.

Class of Evidence: This study provides Class I evidence thatpregabalin 300 mg BID negatively impacts cognition on some tasksin healthy volunteers.

Abbreviations: AED = antiepileptic drug; CI = confidence interval; CLTR = Consistent Long-Term Retrieval; COWAT = Controlled Oral Word Association; GBP = gabapentin; OHSU = Oregon Health & Science University; PGB = pregabalin; PNS = Portland Neurotoxicity Scale; POMS = Profile of Mood States; RT = reaction time; TLTS = Total Long-Term Storage; TREC = Total Recall; WAIS-R = Wechsler Adult Intelligence Scale–Revised.

[Via http://grussell903.wordpress.com]